CTRI Number |
CTRI/2023/08/056702 [Registered on: 21/08/2023] Trial Registered Prospectively |
Last Modified On: |
17/06/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Behavioral |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Attitude, acceptance and productiveness among adult tobacco users after a brief tobacco intervention by dentist - a randomized double blinded controlled trial |
Scientific Title of Study
|
Attitude, receptivity and effectiveness among adult tobacco users after a brief tobacco intervention by dentist - a randomized double blinded controlled trial |
Trial Acronym |
nil |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Bandi Blessi Sravya |
Designation |
Post graduate |
Affiliation |
Sibar institute of dental sciences |
Address |
Sibar institute of dental sciences, department of public health dentistry, room no.10, takkellapadu, guntur, andhra pradesh.
Guntur ANDHRA PRADESH 522509 India |
Phone |
9912024099 |
Fax |
|
Email |
blessibandi1997@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr P Srinivas |
Designation |
Professor & HOD |
Affiliation |
Sibar institute of dental sciences |
Address |
Sibar institute of dental sciences, department of public health dentistry, room no.10, takkellapadu, guntur, andhra pradesh.
Guntur ANDHRA PRADESH 522509 India |
Phone |
9849368466 |
Fax |
|
Email |
srinivaspachava@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Potluri Raja Sekhar |
Designation |
Assistant professor |
Affiliation |
Sibar institute of dental sciences |
Address |
Sibar institute of dental sciences, department of public health dentistry, room no.10, takkellapadu, guntur, andhra pradesh.
Guntur ANDHRA PRADESH 522509 India |
Phone |
7993480971 |
Fax |
|
Email |
sekharpotluri91@gmail.com |
|
Source of Monetary or Material Support
|
SIBAR Institute of Dental Sciences, Takkellapdu, Guntur, Andhra Pradesh |
|
Primary Sponsor
|
Name |
Dr L Krishna Prasad |
Address |
Sibar institute of dental sciences, takkellapdu, guntur, andhra pradesh |
Type of Sponsor |
Other [Private Dental College ( dean)] |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India |
Sites of Study
|
No of Sites = 1 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Bandi Blessi Sravya |
Sibar institute of dental sciences |
room no. 10, department of public health dentistry Guntur ANDHRA PRADESH |
9912024099
blessibandi1997@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee, SIBAR Institute of Dental Sciences |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
Subjects having tobacco habit |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Brief type of behavioral intervention for tobacco cessation counselling |
first day followed by 1st and 2nd week, 1st ,3rd and 6th month from the first visit |
Comparator Agent |
Very brief type of behavioral intervention for tobacco cessation counselling |
first day followed by 1st and 2nd week, 1st ,3rd and 6th month from the first visit |
|
Inclusion Criteria
|
Age From |
25.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Male |
Details |
1)Subjects with tobacco habits visiting the department of public health dentistry in a dental institute as patient attenders
2)Males aged 25-60 years
3)Those who are willing to participate and gives consent for the study.
|
|
ExclusionCriteria |
Details |
1)Due to social barriers, females are excluded from the study.
2)People who are on daily medication for any systemic disease
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
An Open list of random numbers |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
The effectiveness of brief tobacco intervention given by dentist |
1st day, 1st & 2nd week, 1st ,3rd & 6th month from the first visit |
|
Secondary Outcome
|
Outcome |
TimePoints |
The attitudes & receptivity towards the intervention given by dentist |
1st day, 1st & 2nd week, 1st ,3rd & 6th month from the first visit |
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
24/11/2023 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
N/A |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
A total sample of 120 subjects will be selected from the people
having tobacco habits visiting the
department of public health dentistry in a dental institute as patient
attenders. Subjects will be explained the entire
procedure and written consent is obtained from each of them. subjects will be
selected based on inclusion and exclusion criteria. The subjects will be
randomly categorized into 2 groups by a single investigator using randomization
and the groups are named as Group A and Group B containing 60 subjects in each
group. All subjects will undergo clinical examination by single
investigator and oral health status will be assessed by using modified WHO oral health assessment form (1997). Care will be taken in order to match the Group A and Group B in all
the aspects other than the intervention provided. For subjects in group A, Brief tobacco
intervention (BI) is given for 15-30 minutes which includes 5A’s approach (who
are willing to quit) and 5R’s approach (who are not willing to quit) along with
follow-up on 1st and 2nd week, 1st ,3rd
and 6th month from the first visit [11,16]. For subjects
in group B, very brief tobacco intervention (VBA) is given for < 60 seconds
which includes VBA model (ask, advice & act) along with follow-up on 1st
and 2nd week, 1st ,3rd and 6th
month from the first visit. Collection of data will be done before
and after the intervention to both the groups using a questionnaire. Questionnaire is given to obtain assessment of the attitude,
receptivity and effectiveness among adult tobacco users towards the role of
dentists in tobacco cessation programs, prior to the intervention and post
intervention at 6th month by dentist, either through telephone or
the subject is asked to attend and report at the dental institute directly. The responses before and after the intervention
for both the groups will be analysed and compared to assess the effectiveness
of intervention by using statistical tests. |